Some speculating about the PDCO summary

Post by **Fishermangents** » Thu Jun 30, 2016 10:40 am

Repost from Sdrawkcabeman (YHM, 30 June 2016)

Note the PDCO language from the APRIL 2016 summary, "...also taking into consideration the additional information provided by the applicant..."

So what "additional information" did Janssen present that would convince PDCO to recommend a waiver for ALL pediatric pops? There's no doubt about it, right now JNJ and GERN are very well-informed from preclinicals AND data mining from all previous studies, which they would of course share with regulatory bodies like the EMA. And post-study data modeling is a very powerful tool. Hundreds of pts have been on Imet, the joint steering committee will have made further insights that are naturally unavailable to us.

Who knows what's going on behind the curtains. They will positively have seen CR/PRs by now in MF, and I think likely more depth of response in the larger and more diverse pt pop of MDS. These will all inform further study designs. The AML trial will have the significant benefit of a mature program when it starts. And if JNJ and GERN show some derring-do and initiate a trial on the model of the Yale study, it will rock the world of oncology; mark my words on that, it will be on every local news health segment. That kind of abrupt advancement trickles down even to main street. I'll say it again, if the Yale study is successfully extrapolated, were talking about a major human achievement on an historical scale, not just medical history. What are the chances JNJ and GERN aren't aware?

Meanwhile, with approval for MF/MDS, it's highly likely they will revisit MM, and to round off the myeloid blood indications, CML, CMML. Lymphomas and lymphocytic leukemias are a natural next step. We could see the number of trials using Imet expand very suddenly, very soon. And that's really the essence of the interest in Imet, that it can be used alongside myriad treatments to cripple the cancer systematically. We will see a cure for cancer and AIDS in our lifetimes. Imet is a product of that technological advancement of our time.